The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Sandare Hemoglobin Controls.
Device ID | K792209 |
510k Number | K792209 |
Device Name: | SANDARE HEMOGLOBIN CONTROLS |
Classification | Mixture, Hematology Quality Control |
Applicant | SANDARE CHEMICAL CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JPK |
CFR Regulation Number | 864.8625 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-02 |
Decision Date | 1979-12-04 |